Manufacturer registered with FDA
De Götzen S.R.L.
FAGNANO OLONA, Italy. Lists 3 dental device types with FDA across 1 registered establishment, and holds 6 510(k) clearances as applicant.
- Device types listed
- 3
- Brands and models
- 12
- 510(k) clearances
- 62014–2023
- Markets registered in
- 12115 registrations outside the US
- Establishments
- 1Italy
510(k) clearances per year, 2007–2026
Registered in 12 markets
Where regulators' registries name De Götzen S.R.L. as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | De Götzen S.R.L. | 6 clearances | 2014–2023 | Below |
| Canada | Health Canada | Registration holder | DE GOTZEN S.R.L. | 67 | 1999–2025 | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | de Gotzen S.r.l. | 14 | — | Pure Global AI |
| European Union | EUDAMED | Manufacturer | de Götzen S.r.l. | 7 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | de Götzen S.r.l.DE GOTZEN S.R.L. · De Götzen S.r.l. | 7 | 2006–2026 | Pure Global AI |
| Australia | TGA | Manufacturer | De Gotzen SRL | 6 | 2009–2023 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | de Götzen® S.r.l.DE GOTZEN S.R.L. · De Gotzen S.r.l. | 5 | — | Pure Global AI |
| China | NMPA | Registration holder | 蒂高森公司de Gotzen S.r.l.蒂高森公司de Götzen s.r.l. | 2 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | de Gotzen S.r.l | 2 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | DE GOTZEN S.R.L. | 2 | 2025–2026 | Pure Global AI |
| Serbia | ALIMS | Manufacturer | DE GOTZEN SRL | 2 | 2024–2025 | Pure Global AI |
| Philippines | FDA Philippines | Manufacturer | De Gotzen S.r.l. | 1 | 2025–2025 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What De Götzen S.R.L. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Digital Extraoral Source X-Ray SystemMUH · Class 2 | Dental X-ray units | Maker | U-SENSEU-SENSE HDX-MIND optimaX-MIND optima 3DX-MIND primeX-MIND prime 3DX-MIND trium | 2019 |
| Extraoral with Timer X-Ray UnitEHD · Class 2 | Dental X-ray units | Maker | x-mind dcX-MIND unity | 2014 |
| Dental Computed Tomography X-RayOAS · Class 2 | Dental CBCT | Maker | X-MIND optima 3DX-MIND prime 3DX-MIND trium | 2020 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names De Götzen S.R.L. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 28 Dec 2023 | K231055 | x-mind dc (under trademark Acteon), Owandy-RX DC (under trademark OwandyRadiology) | EHD Extraoral with Timer X-Ray Unit |
| 5 Feb 2021 | K203374 | X-MIND prime (under trade mark Acteon), I-MAX (under trade mark Owandy Radiology) | MUH Digital Extraoral Source X-Ray System |
| 18 Nov 2020 | K201382 | X-MIND prime 3D (under trademark Acteon), I-MAX 3D (under trademark Owandy Radiology) | OAS Dental Computed Tomography X-Ray |
| 20 Feb 2020 | K191719 | X-MIND Trium | MUH Digital Extraoral Source X-Ray System |
| 15 Nov 2016 | K160166 | X-MIND trium | OAS Dental Computed Tomography X-Ray |
| 30 May 2014 | K132378 | X-MIND UNITY | EHD Extraoral with Timer X-Ray Unit |
Also lists devices cleared under other names
De Götzen S.R.L. lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Owandy (1).
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| DE GOTZEN S.R.L.FDA reg. 3002994636 | FAGNANO OLONA Varese, Italy | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9012111). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.